DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls— 510(k) K150502

Name: FDA 510(k) clearance K150502
Creator: U.S. Food and Drug Administration
Published: 2015-10-09

Substantially Equivalent

Microgenics Corporation

FDA 510(k) clearance K150502 for DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls, Substantially Equivalent on 2015-10-09. Applicant: Microgenics Corporation. Device class: 2.

Clearance details

Applicant: Microgenics Corporation
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2015-02-26
Decision date: 2015-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DJG

view all

K252684 — Labcorp Fentanyl Urine Visual Test2026-01-29
K250741 — Evidence MultiSTAT DOA Urine MultiPlex2026-01-23
K253082 — LZI Buprenorphine II Enzyme Immunoassay2026-01-16
K252520 — SEFRIA Hydrocodone Oral Fluid2025-09-11
K251972 — Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative +1 more2025-08-15

More clearances from Microgenics Corporation

view all

K243498 — Alinity c Benzodiazepines Reagent Kit2024-12-11
K240670 — DRI Ecstasy Plus Assay2024-10-30
K231020 — Alinity c Tricyclic Antidepressants Reagent Kit2023-11-17
K231007 — CEDIA Heroin Metabolite (6-AM) Assay2023-09-27
K213875 — DRI TM Tricyclics Serum Tox Assay2022-12-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.